Heart Area, Hospital Universitario Central de Asturias, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain; University of Oviedo, Spain.
Heart Area, Hospital Universitario Central de Asturias, Oviedo, Spain; Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Oviedo, Spain; University of Oviedo, Spain.
Int J Cardiol. 2019 Jul 15;287:53-58. doi: 10.1016/j.ijcard.2019.01.094. Epub 2019 Feb 1.
The aim of this study was to assess the safety and effectiveness of valve in valve (VIV) TAVI with the autoexpandable valve, specifically in patients with failed Mitroflow (MF) bioprosthetic aortic valves.
Pilot, single center, observational and prospective study that included 45 consecutive patients with symptomatic failed MF bioprosthetic aortic valve, referred for VIV TAVI. The safety primary endpoint was a composite of early events at 30 days, defined by VARC-2 criteria. The efficacy primary endpoint was the device success (no procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location and absence of moderate/severe prosthetic aortic valve regurgitation). We also analysed patient-prosthesis mismatch (PPM) parameters.
Between March 2012 to December 2017, 45 symptomatic patients (age 79.9 ± 6.5 years) with degenerated MF valves (numbers 19: 33.3%; 21: 28.9%; 23: 24.4%; 25: 13.3%) underwent CoreValve (n = 11) or Evolut R (n = 34) implantation (23 and 26 mm sizes). The STS predicted risk of mortality was 6.3 ± 6.3%. The safety primary endpoint occurred in 4 patients (8.8%). The efficacy endpoint was present in all patients (100%). There were no coronary occlusions or procedural deaths. The number of patients with any degree of PPM raised from 51.1% (pre-TAVI) to 60% (post-TAVI).
Self-expanding TAVI for degenerated MF bioprosthesis has favourable early outcomes. The VIV procedure has provided an important gateway to avoiding high-risk redo surgery and is now a potential option for MF failed surgically aortic implanted valves.
本研究旨在评估经皮主动脉瓣置换术(TAVI)中自膨式瓣膜的安全性和有效性,特别是在二尖瓣血流(MF)生物瓣衰败的患者中。
这是一项单中心、前瞻性、观察性的试点研究,纳入了 45 例因 MF 生物瓣衰败而出现症状、需要行 VIV TAVI 的连续患者。安全性主要终点是 30 天内的早期事件的复合终点,根据 VARC-2 标准定义。有效性主要终点是器械成功(无手术死亡、单个人工心脏瓣膜正确定位至适当解剖位置、无中度/重度人工主动脉瓣反流)。我们还分析了患者-瓣膜不匹配(PPM)参数。
2012 年 3 月至 2017 年 12 月,45 例有症状的 MF 瓣膜退行性病变患者(年龄 79.9±6.5 岁)接受了 CoreValve(n=11)或 Evolut R(n=34)植入术(23 毫米和 26 毫米型号)。STS 预测死亡率为 6.3±6.3%。安全性主要终点发生在 4 例患者(8.8%)中。所有患者均达到了有效性终点(100%)。无冠状动脉闭塞或手术死亡。任何程度 PPM 的患者比例从术前的 51.1%(TAVI 前)增加到术后的 60%(TAVI 后)。
自膨式 TAVI 治疗 MF 生物瓣衰败具有良好的早期结果。VIV 术式为避免高危再手术提供了重要途径,现已成为 MF 生物瓣衰败主动脉瓣植入术后的潜在选择。